America the Home of the Addicted: Opioid Epidemic Diagnosed
Oxycontin's Link to Abuse
Never before have so many become so insidiously addicted. It's as simple as a trip to the doctor. Opioids are used to treat people's chronic physical suffering, surgery, trauma and major diseases like cancer or rheumatoid arthritis. This excellent elixir is a potent analgesic that kills pain so effectively it was prescribed 259 million times in 2015 according to the American Society of Addiction Medicine. For perspective, 300 million people live in the US. Using simple math, this just doesn't add up.
The problem of pain is we don't like it very much as a culture. Who can blame us? Commercials bombard viewers with the reality of the toll people face diagnosed with many medical conditions promising relief by just swallowing a single pill. Conditioned like Pavlov's dog, it's easy to ignore the cornucopia of side effects that come with prescription pain killers.
TV drug disclaimers state, spoken as if the DVR was on hyper-fast-forward, to seek medical attention if sedation, dizziness, vomiting, physical dependence, and respiratory depression occurs which may lead to death. One effect they didn't mention is euphoria. Opioids have made dying fun. For the addict, the high becomes the game they play until they lose and sometimes it's their life that is lost. Family and friends crushed by confusion and despair ask the pertinent question: why?
How could productive people with jobs, loved ones, and most importantly, children make a deal with the drug demon and behave like a heroin hawk in search of the next fix? It's easy to identify the stereotypical opioid addict living on the street nodding off into space with a rig (needle) hanging out of the arm. You'd have to be clairvoyant to recognize a body sentenced to physical dependence who becomes violently ill when their prescription runs out. Fashionably dressed addicts are hard to spot because they'll be physically fine as soon as the dealer, I mean doctor, hooks them up with a new script. How in hell did this happen?
Oxycontin hailed as a revolutionary breakthrough by Purdue Pharmaceutical Company claimed that sustained relief from pain lasted 12 hours. Two pills attained the same effectiveness as up to 18 tablets of other opioids in a 24 hour period. It's similar to having a kale smoothy replace an entire day of nutrition. Like most advertising, the hyperbole didn't stand up to real world experience. The LA Times investigative report uncovered troublesome realities that contributed to the addiction epidemic at the least or outright causation at the worst.
The bottom line? The duration of oxycontin's effectiveness was nowhere close to the 12-hour claim. Like any company with a 31 billion dollar baby, the parent corporation concealed findings from decades-old clinical trials showing the flimsy evidence that made the patent so valuable. In many studies, cancer patients needed additional pain relief well before the magic mark Purdue was shooting for. What did they do? They moved the goal posts and allowed "rescue medication" to be administered in between the 12-hour objective.
In One study, 90% of cancer patients required saving doses of in-between medications. In another, a full 30% of clinical participants dropped out because they claimed oxycontin was ineffective and needed better pain control. This is extremely important not only for chronic pain management but also when talking about the addiction cycle. Dr. Peter Prezekop from the Betty Ford Center of Rehabilitation said repeated instances of withdrawal and the physical symptoms associated "absolutely" increases the rise in abuse.
Purdue had another problem besides long-lasting pain control. In the 1980's, they were about to lose their patent on the cancer drug MS Contin and all the cash that goes with such a drug designation. Emails detail the intense pressure felt by vice president for clinical research, Robert F. Kaiko, with one saying, "MS Contin may eventually face serious competition that other controlled release opioids must be considered." They developed a delayed release formula on the relatively cheap opioid oxycodone creating a Mercedes-Benz alternative in Oxycontin. The soldiers of sales were called to duty and the department of marketing laid out the battle plan.
But first, Oxycontin needed approval from the generals at the FDA. Women recuperating from abdominal and gynecological surgery were given a single dose of the drug while others ingested short-acting painkillers or placebos. Of the 90 participants, over 30% suffered pain before the 8-hour mark and half required "rescue" meds within the all important 12 hour period. Purdue paid for and conducted additional clinical trials and applied for FDA approval. They also requested patents in 1992, claiming "90% of patients" received "pain relief for at least 12 hours." The Oxy marketing operation came to life.
"REMEMBER, EFFECTIVE RELIEF JUST TAKES TWO PILLS," for a 24 hour period the advertisements bombastically bellowed. Who wouldn't want to enjoy such a gigantic reduction in the number of tablets to be swallowed each day? Ads flooding medical journals in 1996 left nothing to the imagination when they highlighted two dosage cups marked 6:00 am and 6:00 pm. The FDA was more nuanced. Sarah Peddicord stated, "it should be well understood by physicians that there will be some individual variability in the length of time that patients respond...carefully individualize their approach to patients based on how quickly they metabolize the drug." The path to hell on earth was paved with gold-plated bonuses.
Patients began reporting the complete failure of the 12-hour dosing schedule. Take Elizabeth Kipp as an illustration of Oxycontin's hell on earth. Kipp injured her back by experiencing an accident riding a horse as a 14-year-old. For the next few decades, she took short-acting generic painkillers when her doctor introduced a brand new drug called Oxycontin. As a trained botanist, she carefully followed her doctor's instructions and took it accordingly. The first 3 to 4 hours provided acceptable relief, but the pain punched back with body shots of nausea. The only answer to suffering: the next pill. Complaints of the situation were met, not with an adjustment of the dosing schedule, by ever increasing strength levels as Purdue instructed. Ms. Kipp clock watched withering from withdrawal waiting for the next pill. She ended up in rehab.
The Bonus Bonanza
In the past, primary care doctors viewed painkilling narcotics as dangerously addictive reserved only for patients in dire circumstances from cancer or the terminally ill. A Purdue marketing executive explained to salesmen, "We don't want to niche Oxycontin just for cancer pain." So they geared up. The company spent $207 million to launch, doubled its sales force to 600, and began pushing the drug to treat common ailments like back pain or knee problems. The marketing mantra was twice-a-day dosing.
It didn't stop there. Sales reps showered doctors with accessories for their office, hats, and paid for flights to junkets at resorts. At the resort meetings, prescribers were encouraged to prescribe Oxycontin and these same doctors encouraged their doctor friends to do likewise. It worked beyond even the highest expectations of Purdue executives. The third year of sales beat revenue for MS Contin by a factor of 2 and by the 5th year Oxycontin produced a billion dollars in sales. Once sales leveled off, Purdue enjoyed sales of 3 billion.
The astonishing increase in sales was mirrored in the practice of prescribing narcotics for common complaints from the general public. Other companies jumped on the Oxy bandwagon and promoted their own opioids for pedestrian injuries. In fact, a John Hopkins University study found 1 out of 5 doctor visits for pain resulted in a narcotic prescription with Oxycontin taking the lion's share of sales at 1/3 of all revenue. The marketing game plan was executed to perfection.
But doctors started to fight back against the 12-hour dosing schedule. Many found patients complaining that pain relief lasted as low as just 4 hours and higher strength only compounded the problem. This resulted in the Bodie lawsuit filed in federal court in 2002. The truth was about to be set free, kinda. The overstatement of duration and fraudulent marketing were key issues that resulted in a settlement for the plaintiff. The details of monetary payment and issues of fraud were sealed from public view.
I wonder why Purdue Pharmaceuticals are afraid of the truth.
Do you think Purdue Pharmaceuticals bear responsibility for the opioid epidemic?
This content reflects the personal opinions of the author. It is accurate and true to the best of the author’s knowledge and should not be substituted for impartial fact or advice in legal, political, or personal matters.
© 2016 Michael Wnek